Moderna Announces New Study Showing Its COVID-19 Vaccine Maintains Antibodies Against Variants of Concern and Interest to 6 Months

Variants studied included Alpha, Beta, Gamma, Delta, Epsilon and Iota

Majority of participants who received primary series maintain detectable blinding and functional antibodies against variants for 6 months

Moderna, Inc. (Nasdaq:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced the publication of new data on the durability of the Moderna COVID-19 vaccine in generating neutralizing antibodies against variants of concern. The manuscript was published in Science. According to the paper, the majority of individuals vaccinated with the Moderna COVID-19 vaccine maintained both binding and functional antibodies against SARS-CoV-2 variants for six months after the second dose.

“We are pleased with these new data showing that people vaccinated with two doses of the Moderna COVID-19 vaccine maintained antibodies through six months, including against variants of concern such as the Delta variant. Along with our partners, we are committed to generating data on the Moderna COVID-19 vaccine and sharing this as available,” said Stéphane Bancel, Chief Executive Officer of Moderna. “These data support the durable efficacy of 93% seen with the Moderna COVID-19 vaccine through six months. We expect that these data and the growing body of real-world evidence will help inform health regulators’ approaches to how and when to administer additional boosting doses.”

This study used a variety of assays and showed that after two doses of the Moderna COVID-19 vaccine, binding and neutralizing antibodies were generated against ancestral strain of the virus and against the variants of concern, Alpha, Beta, Gamma, Delta, Epsilon and Iota. While some waning in antibody levels was observed over time, the majority of participants had detectable neutralizing antibody titers at six months after the completion of the primary series.

A trend towards lower antibody levels against SARS-CoV-2 spike variants was observed in the oldest individuals at Day 209 (through six months). Differences were small, however, and there was overlap between age groups. Importantly, many individuals in the oldest group retained neutralizing activity against the variants six months after the second vaccine dose.

These data complement other recent observations based on real world evidence demonstrating robust longevity of clinical efficacy of the Moderna COVID-19 vaccine¹, effectiveness in the face of rising levels of the Delta variant of concern² and in those harder to treat populations such as those people in long term care facilities³, or those patients living with cancer⁴.

About the Moderna COVID-19 Vaccine

The Moderna COVID-19 Vaccine is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein. On December 18, 2020, the U.S. FDA authorized the emergency use of the Moderna COVID-19 Vaccine in individuals 18 years of age or older. Moderna has received emergency (or other conditional, interim or provisional) authorization for use of its COVID-19 vaccine in adults from health agencies in more than 50 countries and an Emergency Use Listing (EUL) from the World Health Organization (WHO).

The Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS) is supporting the continued research and development of the Company’s COVID-19 vaccine development efforts with federal funding under contract no. 75A50120C00034. BARDA is reimbursing Moderna for 100 percent of the allowable costs incurred by the Company for conducting the program described in the BARDA contract. The U.S. government has agreed to purchase supply of mRNA-1273 under U.S. Department of Defense contract no. W911QY-20-C-0100.

About Moderna

In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna’s capabilities have come together to allow the authorized use of one of the earliest and most effective vaccines against the COVID-19 pandemic.

Moderna’s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Today, 23 development programs are underway across these therapeutic areas, with 15 programs having entered the clinic. Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit www.modernatx.com.

AUTHORIZED USE IN THE U.S.

Moderna COVID-19 Vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older.

IMPORTANT SAFETY INFORMATION

• Do not administer the Moderna COVID-19 Vaccine to individuals with a known history of severe allergic reaction (e.g., anaphylaxis) to any component of the Moderna COVID-19 Vaccine.
• Appropriate medical treatment to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of the Moderna COVID-19 Vaccine. Monitor Moderna COVID-19 Vaccine recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control and Prevention guidelines (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html).
• Reports of adverse events following use of the Moderna COVID-19 Vaccine under EUA suggest increased risks of myocarditis and pericarditis, particularly following the second dose. Typically, onset of symptoms has been within a few days following receipt of the Moderna COVID-19 Vaccine. Available data from short-term follow-up suggest that most individuals have had resolution of symptoms, but information is not yet available about potential long-term sequelae. The decision to administer the Moderna COVID-19 Vaccine to an individual with a history of myocarditis or pericarditis should take into account the individual’s clinical circumstances. The CDC has published clinical considerations relevant to myocarditis and pericarditis associated with administration of the Moderna COVID-19 Vaccine (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/myocarditis.html).
• Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a diminished response to the Moderna COVID-19 Vaccine.
• The Moderna COVID-19 Vaccine may not protect all vaccine recipients.
• Adverse reactions reported in a clinical trial following administration of the Moderna COVID-19 Vaccine include pain at the injection site, fatigue, headache, myalgia, arthralgia, chills, nausea/vomiting, axillary swelling/tenderness, fever, swelling at the injection site, and erythema at the injection site.
• The following adverse reactions have been reported following administration of the Moderna COVID-19 Vaccine during mass vaccination outside of clinical trials:
  • Severe allergic reactions, including anaphylaxis
  • Myocarditis
  • Pericarditis
• Available data on Moderna COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. Data are not available to assess the effects of Moderna COVID-19 Vaccine on the breastfed infant or on milk production/excretion.
• There are no data available on the interchangeability of the Moderna COVID-19 Vaccine with other COVID-19 vaccines to complete the vaccination series. Individuals who have received one dose of Moderna COVID-19 Vaccine should receive a second dose of Moderna COVID-19 Vaccine to complete the vaccination series.
• Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Moderna COVID-19 Vaccine.
• Vaccination providers must complete and submit reports to VAERS online at https://vaers.hhs.gov/reportevent.html. For further assistance with reporting to VAERS, call 1-800-822-7967. The reports should include the words “Moderna COVID-19 Vaccine EUA” in the description section of the report.

Click for Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Full EUA Prescribing Information for more information.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including regarding: the Company’s development of the Moderna COVID-19 Vaccine (mRNA-1273); the ability of the Moderna COVID-19 Vaccine to provide protection against COVID-19 for up to six months and to trigger an antibody response against variants of concern; and the potential for the authorization of booster doses by regulatory authorities. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include those other risks and uncertainties described under the heading “Risk Factors” in Moderna’s most recent Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna’s current expectations and speak only as of the date hereof.

__________________

¹ https://www.medrxiv.org/content/10.1101/2021.08.06.21261707v1

² https://www.medrxiv.org/content/10.1101/2021.08.11.21261885v1

³ https://www.medrxiv.org/content/10.1101/2021.08.06.21261721v1

⁴ https://www.nature.com/articles/s41375-021-01354-7

View source version on businesswire.com: https://www.businesswire.com/news/home/20210812005877/en/